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Recruiting Not applicable

Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2

NCT07252492 · tracked via the Priya Life Science France tracker
Sponsor
Archean Technologies
Phase
Not applicable
Started
2025-09-10
Last updated
2025-11-26

Condition(s) studied

Hearing Loss, Adult-OnsetHearing Aid

Investigational drug(s) / intervention(s)

Audiocap connected hearing aidPlacebo

Audiocap connected hearing aid: The hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path).

Placebo: Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.

Study summary

The goal of this clinical trial is the evaluation of performances, clinical benefits and safety of the 'Audiocap' connected hearing rehabilitation device for improving audibility in hearing-impaired people.

The main question it aims to answer is to demonstrate, after one month's use of the Audiocap connected hearing aid, that the audiological gain for the patient is better than with a placebo hearing aid.

Placebo hearing aid is a Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid).

Participants will be first-time hearing aid users, eligible for hearing aid fitting, and adults according to French legislation (18 years and older).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subjects presenting one or more of the following criteria: a.Subject with mild to moderate hearing loss (20dB to 50dB average at 500, 1000, 2000, and 4000 Hz) in the better ear according to WHO standards, / b. Subject with a speech reception threshold (SRT) in quiet exceeding 30dB, corresponding to the minimum speech level required to achieve 50% recognition in silence (HAS eligibility criteria for hearing aid reimbursement), / c. Subject with significant degradation of speech intelligibility in noise, defined as a speech-to-noise ratio (SNR) deviation greater than 3dB compared to normative reference values (HAS eligibility criteria for hearing aid reimbursement), / d.Subject with high-frequency hearing loss greater than 30dB from 2000 Hz onwards, associated with a speech reception threshold exceeding 30dB in quiet and/or a significantly degraded speech intelligibility in noise (HAS eligibility criteria for hearing aid reimbursement). 2. Subjects eligible for first hearing aid. 3. Subjects over 18 years of age. French-speaking subjects. 5\. Subjects affiliated with a social security scheme. 6. Subjects who are not subject to another medical option, without external pathology and excluding implants. 7\. Subjects who have signed an informed consent. 8. Subjects available for the study. Exclusion Criteria: 1. Subject deprived of his/her liberty by a judicial or administrative decision 2. Subject with severe psychiatric disorder 3. Subject admitted to a health or social care establishment 4. Subject not able to give consent 5. Adults under guardianship or trusteeship. 6. Subjects with disabling tinnitus that are not suitable for adaptation (THI\>56). 7. Subjects eligible for a cochlear implant. 8. Subjects not able to participate in the study according to the investigator. 9. Subjects with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge. 10. Subjects with congenital atresia of external ear or deformity of any part of the ear canal. 11. Subjects with deafness that is unstable and with a degree of hearing loss often fluctuating. 12. Subjects with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation. 13. Subjects with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease. 14. Subjects with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus). 15. Subjects with central deafness (central nervous system) or non-organic deafness. 16. Subjects with acute otitis extrema and tympanitis. 17. Subjects who are allergic to materials of the device.

Primary outcome measure(s)

  • The effectiveness of the Audiocap connected hearing aid will be measured by the improvement of at least one of the following three audiological gain criteria. — After one month of hearing aid use (Month 1)
    The effectiveness of the Audiocap connected hearing aid will be measured by the improvement of at least one of the following three audiological gain criteria: 1. Mean tonal gain of 10 dB (mean 500 / 1000 / 2000 / 4000 Hz). 2. Minimum vocal prosthetic gain of 7 dB (dissyllabic words). 3. Improvement in speech in noise of at least 2 dB SNR (FrMatrix test). Clarification: The primary endpoint measures the audiological gain in decibels (dB) through standard audiometric tests. Three non-cumulative possibilities (i.e., at least one of the three improvements) are defined: depending on the patient's hearing loss, the improvement is not expressed in the same way.

Trial sites (4)

FacilityCityRegionStatus
Hôpital Edouard Herriot Lyon France Not Yet Recruiting
Clinique de l'Oreille Paris France Not Yet Recruiting
Hôpital Lariboisière (APHP) Paris France Not Yet Recruiting
Clinique Rive-Gauche Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252492 on ClinicalTrials.gov ↗ ← All trials in France